Abstract

As drug innovators continue to develop increasingly complex and potent drugs, proper hazard communication is more vital than ever for safety in the workplace. Appropriate documentation is essential to increase awareness of exposure potential for workers. Two systems are often used by the industry to describe hazards and assist with safe handling of new drugs – the UN’s Globally Harmonized System for Classification and Labelling of Chemicals (GHS) and an internal Occupational Health Categorization (OHC) system. Although GHS and OHC systems appear contradictory in print, they are complementary in practice. What follows is an explanation of these synergistic systems. By understanding their similarities and differences, it is easier to see how they work together to facilitate safe handling.

INTRODUCTION

As the pharmaceutical industry continues to advance, active pharmaceutical ingredients (APIs) are becoming more complex and potent. Since drug innovators are outsourcing services to external partners throughout the drug development process, proper hazard communication has become increasingly important for both meeting production timelines and, more importantly, ensuring safe handling of these potent APIs.  Appropriate documentation is essential to increase understanding of exposure potential for workers, and to provide recommendations for proper engineering controls and containment, and/or appropriate PPE selection to prevent exposures during shipping and transport.

Two primary hazard communication documents created early in drug development are the safety data sheet (SDS) and occupational health categorization (OHC) report, with the SDS often being the first official document prepared for a new API. The SDS is a detailed, yet brief and legally-binding document, designed to not only describe intrinsic hazards of a specific chemical or mixture, but also to provide a quick reference for workers in manufacturing, first-responders, and o ...